Your search found 74 Results

  1. 1
    375370

    Hormonal contraceptive eligibility for women at high risk of HIV. Guidance statement. Recommendations concerning the use of hormonal contraceptive methods by women at high risk of HIV.

    World Health Organization [WHO]

    Geneva, Switzerland, WHO, 2017. 20 p. (WHO/RHR/17.04)

    The World Health Organization (WHO) convened a technical consultation during 1-2 December 2016 to review new evidence on the risk of HIV acquisition with the use of hormonal contraception. The issue was recognized as a critical one, particularly for sub-Saharan Africa, where women have a high lifetime risk of acquiring HIV, hormonal contraceptives constitute a significant component of the contraceptive method mix and unintended pregnancy is a common threat to the well-being and lives of women and girls. A wide range of stakeholders were present at this meeting, and serving on the Guideline Development Group (GDG) was global representation from experts in family planning and HIV, representatives from affected populations, clinicians, epidemiologists, researchers, programme managers, policy-makers and guideline methodologists. The GDG considered the following factors in making their determination for each contraceptive method: quality of the evidence (GRADE profile); values and preferences of contraceptive users and health care providers; balance of benefits and harms; priority of the problem; equity and human rights; acceptability; and feasibility. Through consensus, the GDG arrived at new recommendations for progestogen-only injectables. The recommendations for use of progestogen-only injectables among women at high risk of HIV changed from category 1 to category 2, with an accompanying clarification, in the Medical eligibility criteria for contraceptive use (MEC). Recommendations for all other methods of hormonal contraception remained unchanged. (Excerpts)
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  2. 2
    340689

    WHO statement on depot-medroxyprogesterone acetate (DMPA). Key facts.

    World Health Organization [WHO]

    Geneva, Switzerland, WHO, 2015. [2] p. (WHO/RHR/15.09)

    The purpose of this Statement is to reiterate and clarify the existing (current) WHO position based on published guidance that is still valid. WHO monitors the evidence in this field closely and will update its guidance as and when new evidence becomes available. The statement includes key facts about depot-medroxyprogesterone acetate (DMPA), a discussion of the safety of DMPA, and current recommendations for its use.
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  3. 3
    358038
    Peer Reviewed

    Hormonal contraception and risk of HIV acquisition: a difficult policy position in spite of incomplete evidence.

    Farley TM; Lusti-Narasimhan M

    Reproductive Health Matters. 2012 Dec; 20(39 Suppl):14-7.

    Injectable hormonal contraceptives are the most widely used modern contraceptive method in many countries, and are especially popular in sub-Saharan Africa. Some studies have suggested that women using injectable contraception are at a higher risk of acquiring HIV infection that non-users, although other studies have not shown any significant increase in risk. In settings where the risk of HIV infection is high, these conflicting findings present a difficult choice. Modern contraceptive methods, including injectable hormonal contraceptives, are critically important for preventing unintended and mistimed pregnancies, reducing maternal mortality and avoiding the consequences of unsafe abortion. Women and contraceptive providers who advise women in settings where there is a risk of HIV infection are faced with a complex balance of risks regarding contraceptive choice, complicated by the fact that the evidence of whether or not there is an increased risk is far from certain. Furthermore, although additional research has been promised, it may not resolve the question in the near future.
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  4. 4
    332085

    Training and reference guide for a screening checklist to initiate use of DMPA (or NET-EN). Second edition.

    Mueller MP; Lasway C; Yacobson I; Tumlinson K

    Research Triangle Park, North Carolina, Family Health International [FHI], 2009. 79 p. (USAID Cooperative Agreement No. GPO-A-00-05-00022-00)

    This training and reference guide was developed for family planning service providers interested in using the Checklist for Screening Clients Who Want to Initiate DMPA (or NET-EN), commonly referred to as the "DMPA Checklist". Designed to serve as both a training and reference tool, the guide is composed of two parts: a training module and a collection of essential, up-to-date reference materials. The guide is part of a series to train on other checklists. The DMPA Checklist was developed to assist service providers in screening clients who have already been counseled about contraceptive options and who have made an informed decision to use either of two popular injectable contraceptive methods: depot-medroxyprogesterone acetate (DMPA) or norethisterone enantate (NET-EN). This simple job aid is based on the technical guidance provided by the World Health Organization (WHO) in its Medical Eligibility Criteria for Contraceptive Use (2004, updated 2008). The checklist supports the application of these guidelines -- known as the WHO MEC -- into service delivery practice. (Excerpts)
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  5. 5
    331899

    Job aid for DMPA reinjection. For clinicians.

    Family Health International [FHI]; IntraHealth International

    [Research Triangle Park, North Carolina], FHI, 2009. [2] p.

    Clients should be scheduled for DMPA reinjections every 13 weeks. According to the 2008 WHO guidelines, a client can receive a reinjection if she is up to 2 weeks early or 4 weeks past her scheduled reinjection date, without ruling out pregnancy. Clients arriving after the reinjection window may also be eligible if pregnancy can be ruled out. The steps in this aid should be followed for clients who are returning for reinjection. For clients who want an injection for the first time, "Checklist for Screening Clients Who Want to Initiate DMPA".should be used.
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  6. 6
    331839

    Expanding access to injectable contraceptives.

    United States. Agency for International Development [USAID]

    [Washington, D.C.], USAID, [2009]. [2] p.

    A technical consultation, co-sponsored by the World Health Organization (WHO), USAID, and Family Health International (FHI), was held June 15-17, 2009, at the WHO in Geneva to review the evidence and programmatic experience for community-based provision of injectable contraceptives. Thirty technical and program experts from countries and organizations reviewed the scientific evidence and experiences from programs that provided injectable contraceptives through community-based health workers (CHWs). This evidence and programmatic experience came from Africa, Asia, and Latin America and focused on depotmedroxyprogesterone acetate (DMPA). The evidence consistently showed that given appropriate training, CHWs can screen clients effectively, provide DMPA injections safely, and counsel on side effects appropriately, demonstrating competence equivalent to higher level facility-based providers of DMPA. Continuation of use of DMPA by clients of CHWs was as long as those of clients receiving injections at clinics. In addition, the vast majority of clients expressed satisfaction with CHW provision of DMPA. The Consultation concluded that sufficient evidence existed for national policies to support the introduction, continuation, and scale-up of community-based provision of progestin-only injectable contraceptives, especially DMPA. Provision of DMPA by CHWs will expand choice for underserved populations and contribute to reducing the unmet need for family planning. Operational guidelines for family planning should therefore reflect that appropriately trained CHWs can safely initiate use of DMPA and provide reinjection. (Excerpt)
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  7. 7
    331835

    A review of the evidence developed for a technical consultation on expanding access to injectable contraception.

    Malarcher S

    [Research Triangle Park, North Carolina], Family Health International [FHI], 2009 Jun. 48 p.

    The document was prepared to facilitate deliberations for the Technical Consultation on Expanding Access to Injectable Contraceptives sponsored by the World Health Organization, the United States Agency for International Development, and Family Health International, scheduled to be held from 15-17 June 2009 in Geneva, Switzerland. This document summarizes the results of a literature review conducted to identify research evidence and program experience relevant to the objectives of the Technical Consultation: To review systematically the evidence and programmatic experience on interventions designed to expand access to / provision of contraceptive injectables, focusing on non clinic-based services and programs; To reach conclusions on issues: (a) for which evidence is consistent and strong; (b) for which evidence is mixed; and (c) for which evidence is marginal or entirely lacking and, thus requires additional research; To document discussions and conclusions of the Consultation, including policy and program implications, and to disseminate these widely. Use of community-based injectable services was significant in all studies reviewed. This evidence suggests that community-based delivery of injectable services by CHW is acceptable in a wide variety of settings. (Excerpts)
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  8. 8
    331834

    Community-based health workers can safely and effectively administer injectable contraceptives: Conclusions from a technical consultation.

    World Health Organization [WHO]; United States. Agency for International Development [USAID]; Family Health International [FHI]

    Research Triangle Park, North Carolina, FHI, 2009. 4 p.

    In June 2009, a technical consultation held at the World Health Organization (WHO) in Geneva concluded that evidence supports the introduction, continuation, and scale-up of community-based provision of progestin-only injectable contraceptives. The group of 30 technical and programme experts reviewed scientific and programmatic experience, which largely focused on the progestin-only injectable, depot-medroxyprogesterone acetate (DMPA). The experts found that community-based provision of progestin-only injectable contraceptives by appropriately trained community health workers (CHWs) is safe, effective, and acceptable. Such services should be part of a family planning programme offering a range of contraceptive methods. (Excerpt)
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  9. 9
    342791
    Peer Reviewed

    An evidence-based approach to postpartum use of depot medroxyprogesterone acetate in breastfeeding women.

    Rodriguez MI; Kaunitz AM

    Contraception. 2009 Jul; 80(1):4-6.

    This article reviews the evidence and safety of immediate depot medroxyprogesterone acetate (DMPA) use in lactating postpartum women. It presents the benefits for mothers and infants, the concerns, the safety issues, and states that existing data are not sufficient to limit DMPA use postpartum in women at high risk for unintended pregnancy.
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  10. 10
    331727

    USAID-supported research influences international family planning guidelines.

    Family Health International [FHI]

    [Research Triangle Park, North Carolina], FHI, [2008]. [2] p. (Research Brief on Hormonal Contraception)

    The World Health Organization has changed its recommendation on the timing of re-injection for depot medroxyprogesterone acetate (DMPA). The new guidelines encourage health care providers to allow a longer grace period for a woman to return for her next injection of this popular hormonal contraceptive.
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  11. 11
    318979

    Hormonal contraception and bone health.

    World Health Organization [WHO]. Department of Reproductive Health and Research

    Geneva, Switzerland, WHO, Department of Reproductive Health and Research, 2007. [2] p. (Provider Brief)

    Hormonal contraceptives, which include birth control pills, injections, implants, the patch and the vaginal ring, all use hormones to keep a woman from getting pregnant. These hormones can have other health effects for women, many of them beneficial, besides just preventing pregnancy. However, some questions have been raised about how particular hormonal contraceptives, DMPA (depot medroxyprogesterone acetate with trade names of Depo-Provera, Depo-Clinovir and others) and NET-EN (norethisterone enantate or Noristerat, Norigest, Doryxas and others), may affect the health of women's bone. (excerpt)
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  12. 12
    311438

    Using contraceptive checklists in community-based programs: pills and injectables.

    Family Health International [FHI]

    Research Triangle Park, North Carolina, FHI, 2002. [2] p. (FHI Research Brief No. 6; RB-02-06E)

    Community-based workers worldwide use checklists to determine whether women are medically eligible to use combined oral contraceptives (COCs) or depot-medroxyprogesterone acetate (DMPA). However, problems may arise when outdated and inaccurate checklists are used. With input from dozens of experts, Family Health International developed new checklists that are easily understandable and consistent with the World Health Organization's (WHO) medical eligibility requirements. (author's)
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  13. 13
    192541

    WHO recommendations [letter]

    Mansour D

    Journal of Family Planning and Reproductive Health Care. 2004 Apr; 30(2):131.

    May I congratulate the Journal and the Clinical Effectiveness Unit for continuing to produce excellent Guidance for those of us working in the field of reproductive health. The wide dissemination of these articles will ensure uniformity and quality in contraception provision in primary and secondary care. I have, however, one concern. This has been alluded to in a recent article describing the consensus process for adapting the World Health Organization (WHO) Selected Practice Recommendations for UK Use. As a result of the relaxation of some of the more cautious rules a very small number of women may become pregnant. An obvious example is giving Depo- Provera injections 2 weeks late (i.e. at 14 weeks) without any precautionary measures. The Selected Practice Recommendations for Contraceptive Use were developed to improve and extend contraceptive provision in developing countries. In developed countries, however, those becoming pregnant may take a more litigious view particularly when patient information leaflets and the Summaries of Product Characteristics (SPCs) state contrary and more cautious advice. In addition, new evidence regarding follicular development potential suggests that more, rather than less, caution may be advisable. Could the Faculty of Family Planning and Reproductive Health Care or the University of Aberdeen be sued? (excerpt)
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  14. 14
    114088

    Depot medroxyprogesterone acetate contraception and the risk of breast and gynecologic cancer.

    Kaunitz AM

    JOURNAL OF REPRODUCTIVE MEDICINE. 1996 May; 41(5 Suppl):419-25.

    This article reviews recent epidemiological data assessing the risk of breast, endometrial, ovarian, and cervical cancer in women using the injectable contraceptive depot medroxyprogesterone acetate (DMPA). A review is also provided of epidemiological and biostatistical concepts which relate to the literature on the relationship between the use of hormonal contraception and cancer. Breast cancer is a common and lethal disease in the US, and evidence suggests that gonadal steroids play a role in the development of breast cancer. Two major case control studies (one in New Zealand and the other under the auspices of the World Health Organization [WHO]) as well as a pooled analysis of these studies found no increased overall breast cancer risk in DMPA users. A currently unexplained pattern of increased risk in recent users mimics that seen with oral contraceptive (OC) use and term pregnancy. A WHO hospital-based study of the relationship between endometrial cancer and DMPA use found a protective effect of DMPA which appeared to be longterm and as great as that associated with OCs. Whereas it is plausible that DMPA, which suppresses ovulation, would lower the risk of ovarian cancer in users, a WHO case-control and hospital-based study failed to uncover such a protective effect. Studies of the routine use of DMPA in nulliparous women (who have higher risk of ovarian cancer) will shed more light on any effect DMPA may have on ovarian cancer. The unique epidemiology of cervical cancer (including number of sexual partners, use of barrier contraception, and frequent screening) makes it difficult to assess any association with contraceptive use. However, a large population-based, case-control study in Costa Rica; a WHO hospital-based, case-control study in Thailand, Mexico, and Kenya; and a study in New Zealand indicate that the risk of cervical neoplasia does not appear to be affected by DMPA use. While some issues regarding DMPA and the risk of reproductive tract carcinoma remain to be resolved, clinicians can be reassured that, for appropriately selected clients, the substantial benefits of DMPA outweigh any risks.
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  15. 15
    111454

    Invasive cervical cancer risk no greater for DMPA users than for nonusers.

    Remez L

    Family Planning Perspectives. 1992 Sep-Oct; 24(5):239-40.

    The findings of a World Health Organization (WHO) case-control study conducted in Kenya, Mexico, and Thailand suggest that Depo-Provera users are at no greater risk of invasive cervical cancer than non-users (relative risk, 1.1), regardless of duration of use. Women who had used Depo-Provera for 4-8 years were only 10% more likely than non-users to develop cervical cancer, and there was no elevation in risk among women who received their first injection more than 12 years before the interview. The WHO Collaborative Study of Neoplasia and Steroid Contraceptives compared 2009 cervical cancer patients with 9583 controls hospitalized for non-gynecologic conditions. In the Thai and Mexican studies, the cervical cancer risk was slightly but not significantly elevated among women with a history of anal or genital warts (relative risks, 1.24 and 1.61, respectively), but significantly increased among those with herpes simplex type 2 antibodies (relative risk, 1.67). However, these history variables, as well as husband's sexual behavior, had no confounding effect on the association between Depo-Provera use and cervical cancer. There was no alteration in cancer risk among Depo-Provera users according to oral contraceptive use, sexually transmitted disease history, herpes antibody status, age at first intercourse, or husband's exposure to prostitutes.
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  16. 16
    106236

    Long-term use of three-monthly injectable contraceptive DMPA not linked to breast cancer. News release.

    World Health Organization [WHO]. Special Programme of Research, Development and Research Training in Human Reproduction

    Geneva, Switzerland, WHO, Special Programme of Research, Development and Research Training in Human Reproduction, 1995 Mar 20. [2] p. (News Release No. 1/95)

    According to a World Health Organization (WHO) study which was published in the March 8, 1995 issue of the Journal of the American Medical Association, women who use the injectable contraceptive, depot-medroxyprogesterone acetate (DMPA or Depo-Provera), are not at an increased risk of breast cancer, and the use of the contraceptive should not be restricted on the grounds of breast cancer risk. The study was conducted by the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction; the University of Otago Medical School, Dunedin, New Zealand; and the Fred Hutchinson Cancer Research Center, Seattle, Washington, USA. This secondary analysis of combined data from previous studies conducted by three organizations in Kenya, Mexico, New Zealand, and Thailand compared 1768 women who had breast cancer, most under 55 years of age, with 13,905 who did not. Although women who had used DMPA more than 5 years before did not show an increase in risk (even when the period of use had been long), those women who had begun using it within the previous 5 years did. This corresponded to a relative risk estimate of 2.0. This could be due to the enhanced detection of breast tumors in women using DMPA, or to the acceleration of the growth of preexisting tumors. The analysis reconfirmed an increased risk of breast cancer with 1) early menarche; 2) being single; 3) late age at birth of first child; 4) not having had any children; 5) family history of breast cancer; and 6) history of benign breast disease. The authors recommended that patients should be warned concerning the possible accelerated growth of small, undetected tumors.
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  17. 17
    094457
    Peer Reviewed

    Depot-medroxyprogesterone acetate (DMPA) and cancer: memorandum from a WHO meeting.

    Boyle P; Chilvers C; Ferraz E; Hulka B; King R; La Vecchia C; Petitti D; Lumbiganon P; Skegg D; Thomas D

    BULLETIN OF THE WORLD HEALTH ORGANIZATION. 1993; 71(6):669-76.

    Depot-medroxyprogesterone acetate (DMPA) is a highly effective long-acting progestational contraceptive, which is administered by injection. DMPA has been widely used in Thailand and New Zealand. The licensing, acceptability, and prevalence of use have been influenced by concern that DMPA may increase the risk of cancer, in particular cancer of the breast. The results of toxicological tests in animals and epidemiological studies in humans concerning the carcinogenicity of DMPA are reviewed. Animals injected with DMPA were exposed to far greater concentrations of the progestogen than were animals tested with orally administered 19-nortestosterone derivatives. In beagle dogs, a unique response to DMPA led to increased serum growth hormone, which was probably responsible for the tumorigenic effect of DMPA on the mammary gland. However, women taking contraceptive doses of DMPA have no significant elevation of serum growth hormone. Available toxicological data do not seem to indicate that DMPA is different from other progestogens in its tumorigenic potential. Epidemiological studies reassure that use of DMPA does not increase breast cancer risk overall. Elevated risks in the same or similar subgroups were observed in the WHO and New Zealand studies, consistent with an acceleration in detection of pre-existing cancer. The data were not compatible with DMPA as an initiating agent. Research is needed on the biological mechanisms of action of progestogens on the human breast. Findings from studies of DMPA and invasive cervical cancer showed no overall increase in risk of cervical cancer and no association between DMPA and cervical cancer. Data from the WHO study provided evidence that DMPA protects against endometrial cancer and that DMPA use was not associated with either an increased or decreased risk of ovarian cancer. Therefore, restriction of DMPA use as contraceptive on the grounds of risk of neoplasia is not recommended.
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  18. 18
    102903

    New world order and West's war on population.

    Wilson A

    ECONOMIC AND POLITICAL WEEKLY. 1994 Aug 20; 29(34):2,201-4.

    The aim of US-promoted population policies is maintaining and securing the economic and political dominance of capitalist states. Governments of developed countries blame overpopulation in developing countries for destroying the planet and those of developing countries blame overconsumption, waste, and industrial pollution in the capitalist countries to be responsible. Developed countries and the UN profess that population control is in the interests of development and for the sake of women's rights. Many women's groups protest planned and already existing population policies and bear witness to the suffering women from developing countries experience, raising the question of choice of these policies. Sexism served as the smokescreen behind which US strategies of population control were implemented. The concept of sustainable development is also used to advance population policies in developing countries. Developed countries use this concept to maintain the status quo, agricultural countries as such, cash crop economies, dependency on food, foreign aid, and loans and to continue their exploitation in developing countries. USAID, UNFPA, and the World Bank are the major moneylenders for population control. The US targets Africa for population control because it produces 90-100% of four minerals vital to US industry. The new phase of capitalist development has shifted the state's role from its function as a nation state to facilitator of global capital. Population control policy, national security laws, and anti-trade union laws are used to create a docile and immobile pool of labor. The World Bank, the IMF, and the WTO, through their structural adjustment policies, provide the infrastructure to implement population policies and targets. Population policies focusing on targets take control away from women. People in developing countries will not accept these population policies until they have control of their lives. They need assurance of child survival and to be in a position to plan their future. The population control lobby now uses deception to thwart resistance.
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  19. 19
    094446

    USAID negotiating Depo purchase, but shelf life proves problematic.

    FAMILY PLANNING WORLD. 1993 Jul-Aug; 3(4):7, 21.

    The discussion focused on the variations in purchasing agreements for the injectable Depo-Provera. Negotiations are in process between the manufacturer in the US (the UpJohn Company) and USAID regarding size of purchase, prices, and time schedules. A glitch is that the US production plant provides a two-year shelf life for the product, while the Belgian plants provide a three-year shelf life. The one year difference could be significant in the distribution to hard-to-reach places, but the balancing point is that USAIDs effort are a positive development for expanding distribution. The UN Population Fund (UNFPA) and the International Planner Parenthood Federation (IPPF) already distribute Depo-Provera and were charged 72 and 75 cents, respectively; UpJohn recently increased the prices to 80 and 85 cents. The UNFPA prices were slightly lower due to larger purchases, and both concerns will be awaiting the outcome of USAID's price negotiations. Other manufacturers are a company in Indonesia, which sells only within the country, and Organon in Holland, which produces the drug under the name Megstron. UpJohn has the major share of the market. The cost of supplying Depo-Provera also includes the purchase of needles and syringes. Other international agencies are not limited by anything other than finding the lowest cost. UNFPA buys its supplies in Belgium at low cost and its contraceptives in Holland. USAID, however, must purchase needles and syringes from American facilities. IPPF will be watching to assure international organizations that no duplication of effort will occur with the USAID distribution and expects the shelf life problem to be resolved. The issue may be cleared up when UpJohn has sufficient time to resubmit its application with enough research to support the 3-year shelf life; the FDA had rejected Depo-Provera repeatedly since 1961, and the approval was granted on a rushed application that only included some of the Belgian research and could empirically only support a 2-year shelf life.
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  20. 20
    081376

    The future for injectable contraceptives.

    Rutter T

    AFRICA HEALTH. 1993 Mar; 15(3):18-9.

    Until recently, Africa's fertility rates showed no sign of change in spite of the vast resources committed to decreasing population growth. Now there are early indications of success in parts of Nigeria, Botswana, Zimbabwe, and Kenya. In Kenya, between 1984 and 1989, total fertility fell from 7.7 to 6.7, the crude birth rate fell from 52/1000 to 46/1000, and the contraceptive prevalence rate rose from 17% to 27%. Public awareness of modern contraceptive techniques is above 70% in much of Africa, and in Kenya it is up to 90%. Injectable contraceptives are very popular. In October 1992, they were finally licensed by the United States Food and Drug Administration. Injectable contraceptives were first used in Africa in the late 1960s. They were withdrawn from the Bangladesh family planning program, and they were banned in Zimbabwe in 1981. 2 injectable contraceptives administered by deep intra-muscular injection are widely available. Depo medroxyprogesterone acetate (DMPA) or Depo-Provera is normally given in a dose of 150 mg every 12 weeks. Norethindrone enanthate (NETEN) is given in a dose of 200 mg every 8 weeks. DMPA has been used by more than 10 million women. It is repeatedly endorsed by the WHO and the IPPF and has the lowest failure rate of any method of reversible contraception. Side effects include spotting or amenorrhoea, and rarely, menorrhagia. Injectables are suitable for women who are breast feeding, as they may even increase the quantity of breast milk. Norplant, an implanted device developed by the Population Council, releases progestogen at a low, steady rate for 5 years. There is less progestogen in a 5-year Norplant than in the 3-month dose of DMPA. The implant can be removed at any time and fertility is quickly restored. Norplant is becoming increasingly available throughout Africa.
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  21. 21
    077765

    FDA gives final approval to Depo amid concerns over safety, cost and coercion.

    WASHINGTON MEMO. 1992 Nov 12; (17):2-3.

    In October 1992, the US Food and Drug Administration (FDA) approved Depo-Provera for contraceptive use thus increasing the number of available contraceptives to women. Yet USAID has distributed it through its family planning programs in developing countries for many years. It has been available in the US since 1969 for noncontraceptive purposes such as endometrial cancer treatment. More than >30 million women around the world have used it to prevent conception. Today about 9 million women in 90 countries use it. A reason FDA did not approve Depo-Provera is that some studies revealed a link between it and breast tumors and cervical cancer in animals. More recent research conducted by WHO shows no connection with cervical cancer or ovarian cancer. In fact, it demonstrates Depo-Provera may protect against endometrial cancer. Yet it does indicate an insignificant increased risk of breast cancer in younger women. Some research suggests Depo-Provera may decrease bone density leading to osteoporosis and may increase the risk of having a low birth weight infant if the child is conceived before an injection. Evidence exists that it may lead to longer delays in becoming pregnant than other forms of contraception. Still 70% do conceive within 12 months after the last injection. Each Depo-Provera injection delivers a progestin in a water-based solution over 12 weeks resulting in suppressed ovulation. Its failure rate is <.5%/year, so Depo-Provera is one of the most effective reversible contraceptive available. The most common side effects are menstrual changes and weight gain (5-15 lbs.). Some contraindications include pregnancy, heart or liver disease, and breast cancer. As of November 1992, the FDA had not announced the cost or whether there would be a reduced price for family planning and public health clinics. Women's health and rights advocates plan on monitoring introduction of Depo-Provera to make sure that women have received comprehensive information and were not coerced to use it.
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  22. 22
    074000

    Depo-Provera. Controversial contraceptive wins approval from FDA panel.

    Stone R

    SCIENCE. 1992 Jun 26; 256:1754.

    Depo-Provera (DP) was unanimously recommended for approval as a contraceptive by a Food and Drug Administration (FDA) advisory committee. This had happened once before in the mid-1970s, but Congress raised concerns about DP's possible link to cervical cancer. DP has been in use for 20 years as a treatment for uterine cancer. DP is an injectable progesterone analog that induces infertility for 3 months in 99% of the women who use it. It is already in use in 90 countries and has annual sales of US$100 million. The 4 annual shots cost US$120 and is an economical alternative to Norplant. There are still many unanswered questions about its safety. A recent WHO study found that it increased breast cancer by 21%, which was almost statistically significant. However, in the <34 age group breast cancer was twice as common, which is statistically significant. DP was found to increase the number of breast cancer cases by 5.6/100,00; but, it reduced the number of uterine cancer cases by 19.2/100,000. A New Zealand Hospital study found that DP use reduced bone density by 7.5% in the lumber spine and 6.5% in the neck of the femur. Critics charge that Upjohn has had 20 years to compile data but has failed to do so. There is little or no data about its effect on developing fetuses, osteoporosis, or the mechanism that causes breast cancer. All these areas were recommended for follow-up study by the FDA advisory committee.
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  23. 23
    074521

    Update on Depo-Provera [editorial]

    Sapire KE

    SOUTH AFRICAN MEDICAL JOURNAL. 1992 May 2; 81(9):444-5.

    The advantages and side effects of the injectable contraceptive, Depo-Provera, are highlighted. It has been available to women in South Africa and in about 90 developing and developed countries for 20 years. It is an effective and convenient contraceptive with no serious side effects. Its failure rate is 0.2-0.6/100 woman years. Nevertheless there is still concern that it may cause breast cancer because original tests of Depo-Provera using beagles indicated that it may increase breast cancer risk. WHO and the UK Committee on Safety of Medicines have since dropped the requirement of testing of beagles since they cannot predict the effects of steroids on women. A 12-year WHO multinational, hospital-based case-control study on neoplasia and hormonal contraceptives reassures Depo-Provera's safety. For example, the risk of breast cancer did not increase with duration or in women who had used it for >5 years. The risk was higher, however, among women who had used it for <4 years, particularly <35-year old women. The same holds true for oral contraceptive (OC) users. It has been suggested that this slight increase is because Depo-Provera and OCs may accelerate growth of some existing, previously undetected breast tumors. The WHO study verifies that the benefits of Depo-Provera surpass the side effects which include disturbed bleeding patterns, weight gain, and headaches. For example, it decreases the risk of ovarian and endometrial cancer. It is even more beneficial in developing countries where women often suffer from anemia because it increases hemoglobin levels. Further since women in developing countries cannot always comply and take their OCs, Depo-Provera can grant them the protection they need against pregnancy thus saving many lives. Depo-Provera should be available in developed as well as in developing countries.
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  24. 24
    070633
    Peer Reviewed

    Long-term injectable use does not increase risk of breast cancer, but it may lower bone density.

    Remez L

    Family Planning Perspectives. 1992 Jan-Feb; 24(1):43-4.

    1 hospital in Nairobi, Kenya; Mexico City, Mexico, and Chiang Mai, Thailand and 2 hospitals in Bangkok, Thailand took part in a WHO sponsored collaborative study to examine the association between depomedroxyprogesterone acetate (DMPA) and breast cancer. The researchers compared 1979-1988 data on 869 hospitalized women with breast cancer with 11,890 hospitalized women with unrelated conditions. 12.5% of cases and 12.2% of controls had ever had an injection of DMPA. Overall ever users had no significant increased risk of breast cancer (relative risk [RR], 1.2) In addition, risk did not rise with duration. Nevertheless current users who began receiving DMPA within the past 4 years did have a significantly higher risk (RR 2.6). On the other hand, current users who began receiving DMPA >5 years earlier were not at increased risk at all. For example, the RR for those who began 8-12 years earlier was 0.8 and for those who began >12 years earlier was 0.5. Further even though the current users <35 years old who began receiving DMPA within the past 4 years were >2 times as likely to have breast cancer than their corresponding counterparts who did not use DMPA (RR 2.2), the risk according to duration was not significant. The researchers listed some possible reasons for the discrepancies. They concluded that there is only a weak association between DMPA and breast cancer--comparable to that between oral contraceptives and breast cancer. In New Zealand, a case control study of 30 25-51 year old women who used DMPA for at least 5 years showed that long term use of DMPA significantly reduced bone density. For example, for DMPA users, the spine and femoral neck bone densities were 8% and 7% respectively lower than the premenopausal controls. The researchers found the same effect even when they restricted the analysis to nonsmokers.
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  25. 25
    070529

    Once-a-month estrogen/progestogen injectables.

    d'Arcangues C

    ENTRE NOUS. 1991 Dec; (19):15.

    About 8 million women use the long acting injectable contraceptive depot-medroxy-progesterone acetate (DMPA) and norethisterone enanthate (NET-EN). These progesterone only injectables are not dependent on sexual activity and are easy to administer. Yet they are not always well accepted since they can interfere with menstrual bleeding and often induce amenorrhea. Researchers find that adding estrogen to DMPA and NET-EN treats these irregularities. They must use esters with limited action to protect the endometrium from constant estrogens, however, which requires monthly injections. Thus bleeding occurs once a month just like the normal menstrual cycle. Clinical trials in China of Injectable No. 1 (250 mg 17-alpha-hydroxyprogesterone caproate and 5 mg estradiol valerate) show that it has few side effects and is acceptable. Other trials in China are evaluating monthly injectables with NET-EN or megestrol acetate. Numerous developing countries often as WHO's Special Programme of Research in Human Reproduction for effective, safe, and fully studied monthly injectables. WHO operates under a 2 part strategy: optimum improvement of HPR 102 (50 m NET-EN and 5 mg estradiol valerate) and Cyclofem (25 mg DMPA and 5 mg estradiol cypionate) resulting in a reduction of the dose of at least 1 of the hormones and results of a study of the efficacy and side effects of these 2 injectables. It hopes the study provides the impetus to introduce them into national family planning programs. It demonstrates that they are indeed efficacious, effect fewer changes in the menstrual cycle than the progesterone only injectables, and are well accepted, even though women must go to a clinic every 27-33 days for an injection. Other studies are determining their effects on lipid and glucose metabolism, coagulation, and fibrinolysis. They are also looking at the time needed for ovulation to return. 1 study shows that menstruation returned in all women by the 3rd cycle.
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